Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2025-12-26 @ 12:54 AM
Study NCT ID:
NCT00335634
Status:
COMPLETED
Last Update Posted:
2015-12-10
First Post:
2006-06-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Sexual Dysfunction and Adaptation in Couples Affected by Prostate Cancer Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}, {'id': 'D012735', 'term': 'Sexual Dysfunction, Physiological'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-12-09', 'studyFirstSubmitDate': '2006-06-08', 'studyFirstSubmitQcDate': '2006-06-08', 'lastUpdatePostDateStruct': {'date': '2015-12-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-06-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Semi-Structured Interview - Patient', 'timeFrame': '3-6 months post-radical prostatectomy'}, {'measure': 'Semi-Structured Interview - Patient', 'timeFrame': '12-15 months post-radical prostatectomy'}, {'measure': 'Semi-Structured Interview - Patient', 'timeFrame': '21-24 months post-radical prostatectomy'}, {'measure': 'Semi-Structured Interview - Partner', 'timeFrame': '3-6 months post-radical prostatectomy'}, {'measure': 'Semi-Structured Interview - Partner', 'timeFrame': '12-15 months post-radical prostatectomy'}, {'measure': 'Semi-Structured Interview - Partner', 'timeFrame': '21-24 months post-radical prostatectomy'}, {'measure': 'Semi-Structured Interview - Couple', 'timeFrame': '3-6 months post-radical prostatectomy'}, {'measure': 'Semi-Structured Interview - Couple', 'timeFrame': '12-15 months post-radical prostatectomy'}, {'measure': 'Semi-Structured Interview - Couple', 'timeFrame': '21-24 months post-radical prostatectomy'}], 'secondaryOutcomes': [{'measure': 'The International Index of Erectile Function', 'timeFrame': '3-6 months post-radical prostatectomy', 'description': 'Used to assess erectile function, orgasmic function, sexual desire, intercourse satisfaction and overall sexual satisfaction in patients and male partners'}, {'measure': 'Index of Sexual Life', 'timeFrame': '3-6 months post-radical prostatectomy', 'description': 'Used to assess sexual desire and overall sexual satisfaction in female partners'}, {'measure': 'Dyadic Adjustment Scale', 'timeFrame': '3-6 months post-radical prostatectomy', 'description': 'Used to measure couple distress'}, {'measure': 'Hospital Anxiety and Depression Scale', 'timeFrame': '3-6 months post-radical prostatectomy', 'description': 'Used to measure anxiety and depression'}, {'measure': 'The International Index of Erectile Function', 'timeFrame': '12-15 months post-radical prostatectomy', 'description': 'Used to assess erectile function, orgasmic function, sexual desire, intercourse satisfaction and overall sexual satisfaction in patients and male partners'}, {'measure': 'The International Index of Erectile Function', 'timeFrame': '21-24 months post-radical prostatectomy', 'description': 'Used to assess erectile function, orgasmic function, sexual desire, intercourse satisfaction and overall sexual satisfaction in patients and male partners'}, {'measure': 'Index of Sexual Life', 'timeFrame': '12-15 months post-radical prostatectomy', 'description': 'Used to assess sexual desire and overall sexual satisfaction in female partners'}, {'measure': 'Index of Sexual Life', 'timeFrame': '21-24 months post-radical prostatectomy', 'description': 'Used to assess sexual desire and overall sexual satisfaction in female partners'}, {'measure': 'Dyadic Adjustment Scale', 'timeFrame': '12-15 months post-radical prostatectomy', 'description': 'Used to measure couple distress'}, {'measure': 'Dyadic Adjustment Scale', 'timeFrame': '21-24 months post-radical prostatectomy', 'description': 'Used to measure couple distress'}, {'measure': 'Hospital Anxiety and Depression Scale', 'timeFrame': '12-15 months post-radical prostatectomy', 'description': 'Used to measure anxiety and depression'}, {'measure': 'Hospital Anxiety and Depression Scale', 'timeFrame': '21-24 months post-radical prostatectomy', 'description': 'Used to measure anxiety and depression'}, {'measure': 'Brief Profile of Mood States', 'timeFrame': '3-6 months post-radical prostatectomy', 'description': 'Used to measure emotional distress'}, {'measure': 'Brief Profile of Mood States', 'timeFrame': '12-15 months post-radical prostatectomy', 'description': 'Used to measure emotional distress'}, {'measure': 'Brief Profile of Mood States', 'timeFrame': '21-24 months post-radical prostatectomy', 'description': 'Used to measure emotional distress'}, {'measure': 'Miller Social Intimacy Scale', 'timeFrame': '3-6 months post-radical prostatectomy', 'description': 'Used to measure patient-partner intimacy'}, {'measure': 'Miller Social Intimacy Scale', 'timeFrame': '12-15 months post-radical prostatectomy', 'description': 'Used to measure patient-partner intimacy'}, {'measure': 'Miller Social Intimacy Scale', 'timeFrame': '21-24 months post-radical prostatectomy', 'description': 'Used to measure patient-partner intimacy'}, {'measure': 'Sternberg Triangular Love Scale', 'timeFrame': '3-6 months post-radical prostatectomy', 'description': 'Used to assess levels of intimacy (closeness and connectedness), commitment and decisions to love, and passion'}, {'measure': 'Sternberg Triangular Love Scale', 'timeFrame': '12-15 months post-radical prostatectomy', 'description': 'Used to assess levels of intimacy (closeness and connectedness), commitment and decisions to love, and passion'}, {'measure': 'Sternberg Triangular Love Scale', 'timeFrame': '21-24 months post-radical prostatectomy', 'description': 'Used to assess levels of intimacy (closeness and connectedness), commitment and decisions to love, and passion'}]}, 'conditionsModule': {'keywords': ['Prostate Cancer', 'Radical Prostatectomy', 'Sexual Dysfunction', 'Intimacy', 'Adaptation', 'Psychosocial Oncology'], 'conditions': ['Prostate Cancer', 'Erectile Dysfunction Following Radical Prostatectomy', 'Sexual Dysfunction']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to explore patient and partner experiences with sexual dysfunction following radical prostatectomy, in order to understand its effects on sexual and non-sexual intimacy. This will enable us to provide assistance in the future to individuals experiencing similar circumstances.', 'detailedDescription': 'We are studying the impact of sexual dysfunction following radical prostatectomy on patient and partners\' experiences of intimacy. Research with men in post-radical prostatectomy recovery indicates 25%-75% experience sexual dysfunction. Many patients experience anxiety and distress related to sexual difficulties. These experiences may progress and result in long-term problems in the relationship between patients and their partners. Despite apparent levels of effectiveness, up to half of the patients who turn to sexually assistive aids after surgical removal of the prostate discontinue use of the aids within one year. Additionally, difficulties in communicating about sexual impairments can significantly interfere with the couples\' ability to achieve successful adaptation. We are interested in studying patient and partner experiences with sexual dysfunction in order to understand its effects on sexual and non-sexual intimacy.\n\nParticipation in this study will involve completing 6 confidential face-to-face interviews on three separate occasions (3-6 months, 12-15 months, and 21-24 months post-surgery). On each occasion, participants will be required to take part in a "couple\'s" interview with his/her partner, as well as an individual interview. The interviews will provide participants with the opportunity to discuss the impact of sexual dysfunction on mood, thoughts, and communication with their partners. Demographic information will be collected at the initial interview. As well, at each of the 3 time points, participants will also be asked to complete a questionnaire package containing 6 psychological questionnaires. All questionnaires and interview material will be kept strictly confidential.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '35 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Men with prostate cancer who have had a radical prostatectomy, and their intimate partners.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Radical prostatectomy treatment for prostate cancer at Princess Margaret Hospital or Etobicoke General Hospital\n* At least 3 months, but less than 6 months post-radical prostatectomy\n* Experience sexual dysfunction as a result of radical prostatectomy\n* Must have an intimate partner and be able to participate as a couple\n\nExclusion Criteria:\n\n* Detectable prostate specific antigen (PSA) post-radical prostatectomy\n* Patient or partner unable to speak English\n* Patient or partner unwilling to allow interviews to be recorded\n* Patient or partner unwilling to participate'}, 'identificationModule': {'nctId': 'NCT00335634', 'briefTitle': 'Sexual Dysfunction and Adaptation in Couples Affected by Prostate Cancer Surgery', 'organization': {'class': 'OTHER', 'fullName': 'University Health Network, Toronto'}, 'officialTitle': 'Sexual Dysfunction and Adaptation in Couples Affected by Prostate Cancer Surgery: Steps Towards a Bio-Psychosocial Model of Treatment', 'orgStudyIdInfo': {'id': 'PC-05-0813'}}, 'contactsLocationsModule': {'locations': [{'zip': 'M9V 1R8', 'city': 'Etobicoke', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Etobicoke General Hospital', 'geoPoint': {'lat': 43.64415, 'lon': -79.56985}}, {'zip': 'M5G 2M9', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'The Prostate Centre, Princess Margaret Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Andrew G Matthew, PhD, C.Psych', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Health Network, Toronto'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Health Network, Toronto', 'class': 'OTHER'}, 'collaborators': [{'name': 'Canadian Institutes of Health Research (CIHR)', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}